Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1
54 participants
INTERVENTIONAL
2021-07-12
2039-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies
NCT04245722
FT516 in Subjects With Advanced Hematologic Malignancies
NCT04023071
Fludarabine, Bendamustine, and Rituximab (FBR) for Relapsed Chronic Lymphocytic Leukemia (CLL)
NCT01096992
Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL
NCT05153330
S0902 Bendamustine and Rituximab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Not Responded to Previous Treatment
NCT00939328
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FT819 Single-Dose Monotherapy, B-Cell Lymphoma
FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma
FT819
Experimental Interventional Therapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
Bendamustine
Lympho-conditioning agent
FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
FT819
Experimental Interventional Therapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
IL-2
Biologic response modifier
Bendamustine
Lympho-conditioning agent
FT819 Step Fractionated Monotherapy, B-Cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma
FT819
Experimental Interventional Therapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
Bendamustine
Lympho-conditioning agent
FT819 Single-Dose Monotherapy, CLL
FT819 single-dose monotherapy in adult subjects with r/r CLL
FT819
Experimental Interventional Therapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
Bendamustine
Lympho-conditioning agent
FT819 Single-Dose in Combination with IL-2, CLL
FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL
FT819
Experimental Interventional Therapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
IL-2
Biologic response modifier
Bendamustine
Lympho-conditioning agent
FT819 Step Fractionated Monotherapy, CLL
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL
FT819
Experimental Interventional Therapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
Bendamustine
Lympho-conditioning agent
FT819 Single-Dose Monotherapy, B-ALL
FT819 single-dose monotherapy in adult subjects with r/r B-ALL
FT819
Experimental Interventional Therapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
Bendamustine
Lympho-conditioning agent
FT819 Single-Dose in Combination with IL-2, B-ALL
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL
FT819
Experimental Interventional Therapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
IL-2
Biologic response modifier
Bendamustine
Lympho-conditioning agent
FT819 Step Fractionated Monotherapy, B-ALL
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL
FT819
Experimental Interventional Therapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
Bendamustine
Lympho-conditioning agent
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
FT819
Experimental Interventional Therapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
IL-2
Biologic response modifier
Bendamustine
Lympho-conditioning agent
FT819 Step Fractionated Monotherapy in Combination with IL-2, CLL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL
FT819
Experimental Interventional Therapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
IL-2
Biologic response modifier
Bendamustine
Lympho-conditioning agent
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL
FT819
Experimental Interventional Therapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
IL-2
Biologic response modifier
Bendamustine
Lympho-conditioning agent
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FT819
Experimental Interventional Therapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
IL-2
Biologic response modifier
Bendamustine
Lympho-conditioning agent
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
B-Cell Lymphoma:
* Histologically documented lymphomas expected to express CD19
* Relapsed/refractory disease following at least 2 prior lines of multi-agent immunochemotherapy
Chronic Lymphocytic Leukemia (CLL):
* Diagnosis of CLL per iwCLL guidelines
* Relapsed/refractory disease following at least two prior systemic treatment regimens
Precursor B-cell Acute Lymphocytic Leukemia (B-ALL):
* Diagnosis of B-ALL by flow cytometry, bone marrow histology, and/or cytogenetics
* Relapsed/refractory disease after at least 2 cycles of standard multiagent induction chemotherapy. For subjects with Philadelphia-chromosome positive (Ph+) disease, failure or intolerance to a tyrosine kinase inhibitor therapy-containing regimen
ALL SUBJECTS:
* Capable of giving signed informed consent
* Age ≥ 18 years old
* Stated willingness to comply with study procedures and duration
* Contraceptive use for women and men as defined in the protocol
Exclusion Criteria
* Females who are pregnant or breastfeeding
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
* Body weight \<50 kg
* Evidence of insufficient organ function
* Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Day 1
* Currently receiving or likely to require systemic immunosuppressive therapy
* Ongoing requirement for systemic GvHD therapy following prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T
* Receipt of an allograft organ transplant
* Known active central nervous system (CNS) involvement by malignancy
* Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
* Clinically significant cardiovascular disease
* Positive serologic test results for HIV infection
* Positive serologic and polymerase chain reaction (PCR) test results for Hepatitis B (HBV) infection
* Positive serologic and PCR test results for Hepatitis C (HCV) infection
* Live vaccine \<6 weeks prior to start of lympho-conditioning
* Known allergy to albumin (human) or DMSO
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fate Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fate Trial Disclosure
Role: STUDY_DIRECTOR
Fate Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Arizona
Phoenix, Arizona, United States
UC Davis
Davis, California, United States
Scripps Green Hospital
La Jolla, California, United States
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Mayo Florida
Jacksonville, Florida, United States
University of Iowa
Iowa City, Iowa, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States
Mayo Minnesota
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Oregon Health & Sciences University
Portland, Oregon, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
ASH 2022 Poster Presentation
ASH 2022 Abstract
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FT819-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.